This is a continuation-in-part of the earlier filed patent application Ser. No. 09/024,162 filed on Feb. 17, 1998, now U.S. Pat. No. 6,038,480 which is a continuation-in-part of patent application Ser. No. 08/627,576 filed on Apr. 4, 1996, now abandoned, for which priority is claimed. These applications are incorporated herein by reference in their entireties.

1. Field of the Invention

This invention relates to an implantable system for stimulating electrically excitable tissue within a patient and more particularly relates to such a system in which the stimulating electrodes are selectable while minimizing the number of conductors within the lead.

2. Description of the Related Art

Often it is desirable with spinal cord or deep brain stimulation for pain relief or control of movement disorders to have many stimulation electrodes on a stimulation lead in order to place one or more cathodes and one or more anodes in optimal locations to produce benefits or minimize undesirable side effects. Implanted systems now use one to three leads and have between one and sixteen stimulation electrodes. Such systems typically must pass up to 20 milliamperes of current or more, involving current densities of 10 microcoulombs per square centimeter per phase or more. As a result, each electrode is connected to a sizable conductor in order to minimize energy losses due to impedance and to provide adequate strength to connect the wire to a power supply without substantial risk of breakage. Most current systems have the ability to program the polarity of each electrode. Due to size limitations and properties of conductors, it is difficult to have high reliability when there are eight, sixteen or more wires within a lead body that is implanted in a patient.

A lead with twenty to fifty or more stimulation electrodes could be useful for some therapies. Optimal combinations of cathodes and anodes could be selected for each patient. However, the use of this many electrodes has not been feasible in the past because of the size limitations imposed by the need to have a sizable conductor connected to each electrode. The present invention is directed to solving this problem.

A tripole lead is shown in PCT Publication No. WO95/19804 (Jul. 27, 1995), which is incorporated herein by reference in its entirety. However, such a lead lacks the ability to reprogram electrodes, and clinical benefit is critically dependent on electrode positioning. U.S. Pat. Nos. 5,713,922 and 5,925,070 disclose a system for adjusting the locus of excitation of tissue using two or three electrical leads, however, such systems are limited in the range of adjustment that can be made. Both of these patents are incorporated herein by reference in their entireties. This invention overcomes the disadvantages of the foregoing lead by allowing changes in an effective stimulation area after implant by programming.

An additional shortcoming of prior art nuerostimulation paddle leads is that they require implantation via invasive surgery. Accordingly, there is a need for a percutaneous lead that does not require implantation via invasive surgery.

The invention is useful for interacting with electrically excitable tissue of a patient. According to a preferred embodiment, a group of implantable electrodes is adapted to interact with the tissue. A main cable extends from a first site to a second site adjacent the tissue. A source of data identifies one or more of the electrodes within the group, and a data conductor extends from the source of data to the second site. An implantable controller is responsive to the data for gating one or more of the electrodes to the main cable.

The invention enables electrical signals to be transmitted between the first site and one or more selectable electrodes within the patient with a minimum number of conductors. As a result, the number of electrodes implanted in the patient can be substantially increased in order to provide improved therapeutic effects. By minimizing the number of conductors, reliability is improved.

According to another embodiment of the invention, the electrodes include both recording electrodes and stimulating electrodes.

In another embodiment, the present invention is a multi-electrode percutaneous lead that allows stimulation from any one of a number of electrodes with the use of three or fewer conductors to the signal generator.

These and other advantages and features of the invention will become apparent upon reading the following detailed description and referring to the accompanying drawings in which like numbers refer to like parts throughout and in which:

FIG. 1 is a top plan diagrammatic view of a preferred form of stimulation lead incorporating a stimulation assembly made in accordance with the present invention implanted within a patient and connected to a source of data;

FIG. 2 is a side elevational view of the lead shown in FIG. 1;

FIG. 3 is a top plan diagrammatic view of a preferred form of recording assembly made in accordance with the present invention;

FIG. 4 is a top plan diagrammatic view of modified form of lead in which the stimulation assembly of FIG. 1 and the recording assembly of FIG. 3 are combined using multiple controllers;

FIG. 5 is a top plan diagrammatic view of another form of the invention employing multiple arrays of stimulation electrodes and an array of recording electrodes that are controlled by a single controller;

FIG. 6 is a side elevational diagrammatic view of another form of the invention employing multiple electrodes on a nearly cylindrical lead;

FIG. 7 is a diagrammatic end view of the lead shown in FIG. 6 and rotated slightly from the view shown in FIG. 6;

FIG. 8 is an enlarged view of FIG. 7;

FIG. 9 is a top plan diagrammatic view of another form of the invention in which the data conductor and one of the power conductors are multiplexed into a single line;

FIG. 10 is a top plan diagrammatic view of another form of the invention employing multiple controllers wherein each controller controls one or more of the stimulation electrodes in the array;

FIG. 11 is an exploded side elevational view of one of the stimulation electrodes of the lead shown in FIG. 10;

FIG. 12 is a top plan diagrammatic view of another form of the invention employing multiple controllers wherein each controller controls one or more of the stimulation electrodes in the array and a power conductor is modulated with a data conductor;

FIG. 13 is an exploded side elevational view of one of the stimulation electrodes of the lead shown in FIG. 12;

FIG. 14 is a simplified diagrammatic view of a preferred form of multi-electrode stimulation lead coupled to a signal generator in accordance with the present invention.

FIG. 15 is a more detailed view of a preferred embodiment of a multi-electrode stimulation lead similar to the lead of FIG. 14.

FIG. 16 is a simplified circuit diagram of an electrode of the stimulation lead of FIG. 15.

Referring to FIG. 1, a preferred form of flat paddle lead L1 suitable for implantation into a patient basically comprises a stimulation assembly S1 that includes a controller C1 and an array of stimulating electrodes AS1. Lead L1 is implanted at a site IS1 within a patient adjacent tissue to be stimulated. Array AS1 includes fifty-five electrodes, such as flat electrodes 10-12, arranged in a rectangular grid and electrically insulated from each other. The top surface of array AS1 is exposed to patient tissue at the surface of lead L1. Controller C1 is connected to a conductor ID1 over which data is provided, from a data source D1, as well as a cable CB1 comprising power conductors P1 and P2 for conducting stimulating current to electrode array AS1. P1 and P2 are connected to a power source not shown. Controller C1 is coupled to each electrode in electrode array AS1 with separate conducting wires. Data source D1 is located at a site OS1 which could be located within the power source or at another location, usually subcutaneous. The data source may be a microprocessor including a memory for storing data that identifies electrodes to be activated and their polarities.

The FIG. 1 embodiment is especially good for red skeletal muscle, since stimulation on such a muscle can only activate the muscle fibers directly under the cathode. Action potentials do not spread from muscle fiber to fiber, as they do in smooth muscle or cardiac muscle. Hence, a broad array of cathodes is useful to recruit many fibers of a red muscle.

Referring to FIG. 2, lead L1 also may optionally include another array of stimulating electrodes AS2, including electrodes such as 15-17, that is arranged on a side of lead L1. The surface of the electrodes in array AS2 is exposed at the side of lead L1 to electrically stimulate tissue of a patient at site IS1. Electrodes in array AS2 may be controlled by C1 and/or a separate controller C2 as shown.

Referring to FIG. 1, each electrode in array AS1 and AS2 is coupled to controller C1 and/or C2 via conductor wires. A signal is sent to controller C1 and/or C2 along conductor ID1 which identifies the electrodes to be activated. Controllers C1 and C2 act as switching gates coupling power lines P1 and P2 to the activated electrodes in array AS1 and AS2. Some activated electrodes may become cathodes (−) and other electrodes may become anodes (+). The plus signs and minus signs in FIG. 1 indicate electrodes which have been activated as anodes (+) and cathodes (−), respectively. Electrodes not chosen to be activated will be open circuit or will have a high impedance. The arrangement of anodes or cathodes on assembly S1 can be chosen by the patient or through investigation by clinicians to maximize the desired effects of stimulation, e.g., maximize pain relief, minimize spasticity, stop seizures, cause contraction of muscles, etc., and also to minimize undesirable side effects.

Still referring to FIG. 1, power conductors P1 and P2 carry the stimulation current necessary in order to stimulate the electrically excitable tissue adjacent lead L1. For monopolar stimulation, a single one of conductors P1 and P2 would suffice; but for bipolar stimulation, two power conductors (single channel), such as P1 and P2 are needed. For dual channel applications, three or four power conductors may be used. Fewer wires may suffice if the power signal is time division multiplexed.

FIG. 9 illustrates an embodiment of the present invention having two conductors leading to lead L1. Conductors P1 and ID1 of FIG. 1 are combined into a single conductor. The P1 and ID1 signals are modulated, thereby reducing the need for a third conductor. The modulation of the data signal of ID1 and the power signal of P1 or P2 may be accomplished by any number of modulation techniques including, but not limited to, Amplitude Modulation (AM), Frequency Shift Keying (FSK), Phase Shift Keying (PSK), pulse position timing and any combination thereof.

Referring back to FIG. 1, each of electrodes in arrays AS1 and AS2 is between 1-6 mm in area, but other sizes also may be used. Typically, several neighboring electrodes are connected in parallel to have a combined surface area of 6-24 mm², but other sizes also may be beneficial. The electrodes in arrays AS1 and AS2 are electrically conductive, and usually are made from a metal like platinum or iridium. In FIG. 1, four electrodes have been programmed to be anodes (+) and six electrodes have been programmed to be cathodes (−).

The invention is useful in connection with electrically excitable tissue which includes both neural tissue and muscle tissue. Neural tissue includes peripheral nerves, the spinal cord surface, the deep spinal cord, deep brain tissue and brain surface tissue. Muscle tissue includes skeletal (red) muscle, smooth (white) muscle, and cardiac muscle.

FIG. 3 illustrates a preferred form of recording assembly R1 which includes a controller C2 and an array of recording electrodes RE1-RE5 electrically insulated from each other. Assembly R1 is implanted inside a patient at a site IS2. Controller C2 is provided with a conductor ID2 for transmitting data and a cable CB2 that includes power conductors P3 and P4, as well as an additional conductor RD1 used to transmit recorded and amplified tissue potentials received by one or more of conductors RE1-RE5. Conductor RD1 may be five separate conductors connected to electrodes RE1-RE5 or a single conductor on which potentials from electrodes RE1-RE5 are transmitted by time division multiplex techniques executed by controller C2. Alternatively, controller C2 might activate combinations of electrodes RE1-RE5 as stimulating electrodes to provide stimulation of tissue.

Recording assembly R1 can be used to record potentials in electrically excitable tissue. Controller C2 selects from among recording electrodes RE1-RE5, amplifies the signals received by the recording electrodes and sends the amplified signals over conductor RD1 to a recording instrument RC1. Controller C2 also could filter or otherwise process the signals. Instrument RC1 is located at another site, possibly OS1.

Referring to FIG. 3, under each recording electrode RE1-RE5 is an electrical circuit consisting of an operational amplifier and a gating circuit to turn on or turn off the recording electrode. A recording electrode may be chosen with optimal signal strength and discrimination of the potential of interest. Two or more electrodes may be connected together in parallel to lower impedance or may be used differentially to better shape the recorded potential and remove noise signals. Alternatively, controller C2 may control all signal conditioning functions and gating circuits, particularly if the dimensions of recording assembly R1 are small.

Conductor ID2 is used to carry data from a data source, such as D1, to controller C2. In response to the data, controller C2 activates the desired electrodes and adjusts the amplification. Cable CB2 is used to bring power to controller C2. Conductor RD1 exits from the recording site IS2 to bring the amplified recorded potentials to recorder RC1. The recording electrodes each typically have an impedance between 100,000 ohms and 1.5 megohms, but other impedances may be desirable.

FIGS. 4 and 5 show the flexibility of controllers and arrays of stimulation electrodes and optional recording electrodes made in accordance with the invention. Referring to FIG. 4, a lead L2 may comprise stimulating assembly S1 and optional recording assembly R1, as well as additional stimulating assemblies S2 and S3 that may be identical to assembly S1. Additional stimulating or recording assemblies may be added to S1 by the practitioner during implant. Conductor RD2 carries recorded potentials to a recorder, such as RC1 shown in FIG. 3. Conductor RD2 may be an extension of conductor RD1, or may contain additional data resulting from processing done in controller C1 of assembly S1. For the configuration shown in FIG. 4, controller C1 of assembly S1 may incorporate the functions of controllers C1 and C2 described in connection with FIGS. 1 and 3. Alternatively, controllers C4 and C5 may provide control to assemblies S2 and S3 respectively. Power is furnished to assemblies S2 and S3 by power conductors P1 and P2. A conductor ID3 communicates the data necessary to identify the stimulation electrodes within assembly S2 that need to be activated. A similar function is performed for assembly S3 by a data conductor ID4. Controller C1 processes the data on conductor ID1 in order to provide the appropriate data for assemblies S2 and S3 that is transmitted over conductors ID3 and ID4, respectively. With modulation of power signals on conductors P1 and P2, data conductors ID1, ID3 and ID4 may be unnecessary.

Referring to FIG. 5, a lead L3 carries a controller C3 that is connected to array AS1 and an identical array AS2, as well as array AR1. Each of the recording electrodes in array AR1 is connected to controller C3 by one of conductors RL1-RL5. Each of the stimulating electrodes on assembly AS1 is connected to controller C3 by a cable CB6, which contains individual conductors connected separately to each of the electrodes in assembly AS1. Similarly, each of the stimulating electrodes in assembly AS2 is connected to controller C3 through a cable CB7. Controller C3 receives information on conductor ID1 which identifies the electrodes of assemblies AS1 and AS2 which are to be activated, as well as the polarity of the electrodes. Controller C3 activates the electrodes in assemblies AS1 and AS2 in the same manner described in connection with controller C1 of FIG. 1.

The potentials transmitted by each of conductors RL1-RL5 are transmitted by controller C3 on a time division multiplex basis on output conductor RD2. RD2 may be connected to a recorder such as RC1 shown in FIG. 3.

FIG. 6 illustrates a generally cylindrical lead L4 carrying a controller C4 and an assembly of twenty-two stimulating electrodes AS3, including cylindrical electrodes 20 and 21 arranged as shown. Inside the body of lead L4 and mounted directly on electrodes 20 and 21 are corresponding electrical circuits CT1 and CT2 (FIGS. 7 and 8). For stimulating assembly AS3, circuits CT1 and CT2 are electrical switches or gates which activate specified electrodes in the assembly in accordance with the data received on conductor ID1. If there is only one electrode at each longitudinal position of the lead, it could be a ring electrode. If there is more than one electrode at each longitudinal position, the electrodes at each longitudinal position could occupy equal sectors of the cross-section of lead L4. Then, by use of controller C4, only those electrodes nearest the excitable tissue could be used for stimulating or recording. A complex lead may be assembled in the operating room by plugging any number of cylindrical extensions onto lead L4 (FIG. 6).

A recording assembly can be made in the same form as assembly AS3 shown in FIG. 6. In this case, the electrodes would perform the same recording function described in connection with FIG. 3. In such an embodiment, circuits CT1 and CT2 would be an amplifier and switchable gate that would transmit a tissue potential to controller C4.

FIG. 10 is a top plan diagrammatic view of another embodiment of the invention employing multiple controllers wherein each controller controls one or more of the stimulation electrodes in the array. FIG. 10 illustrates a lead L5 having a stimulation assembly S5 that includes an array of controllers (not shown) and a corresponding array of stimulation electrodes AS5. Power conductors P1 and P2 and data signal ID1 connect to lead L1 similar to that of FIG. 1. Alternatively, as shown in FIG. 12, power conductor P1 may be modulated with data conductor ID1 using any number of modulation techniques thereby reducing the number of conductors to lead L5.

Referring to FIG. 10, each stimulation electrode with in the array AS5 has a corresponding controller which controls the operation of that electrode. Power signals P1 and P2 and data signal ID1 are provided to each of these individual controllers which in turn control the operation of the associated stimulation electrodes based on these signals. In such an embodiment, controller C1 (as shown in FIG. 1) would not be required. FIG. 11 is an exploded side elevational view of an individual controller C5 and the associated stimulation electrode E5 of lead L5. Power lines P1 and P2 and data line ID1 run to each controller in lead L5 including controller C5. Alternatively, as shown in FIG. 13, power conductor P1 may be modulated with data conductor ID1 using any number of modulation techniques thereby reducing the number of conductors to lead controller C5. FIG. 11 depicts a typical electrode/controller pair combination of lead L5. Controller C5 may be an integrated circuit (IC) and the conductors leading to controller C5 may be wirebonded to controller C5. Each electrode/controller pair has a unique address such that data conductor ID1 may designate which electrodes are to be activated based on the address information carried by the data conductor ID1. For each electrode designated for activation, the electrode is designated as an anode (+) or a cathode (−). As another embodiment, controller C5 may be positioned to control the operation of a number of electrodes. Controller C5 may also be used to control recording electrodes.

Each of assemblies AS1-AS3, AS5 and AR1 may be silicon wafers, and thus rigid. Controllers C1-C5 may be conventional microcontrollers capable of executing instructions stored in memory. Other parts of leads L1-L5 may be flexible and inert, or flexible and carry wires, such as assemblies AS1, AS2, and AR1 of FIG. 5. Flexible electrical circuits or ribbon cables also could be used to advantage.

Leads L1-L5 offer several advantages over known leads. One does not always know before implant what is the best strategy for lead placement and electrode polarity. Leads L1-L5 allow the choice to be made later, and additional reprogramming at later dates, to give degrees of freedom in electrode position. It is sometimes useful to have five or more electrodes in a line (especially transverse to the spinal cord axis), so that two or three can be chosen at preferred medial/lateral positions. The preferred embodiments enable changes in effective stimulation area after implant by programming only.

One key need for practitioners using spinal cord stimulation is to position one or more electrodes on the “physiological midline”. This means that pulses will give balanced effects, and not be biased unduly on one or the other side (near one or the other dorsal root). When using the location of the vertebral canal for lead placement, only 27% of the time is the paresthesia balanced (Barolat, G., Zeme, S. and Ketcik, B., Multifactorial analysis of epidural spinal cord stimulation, Stereotact. Funct. Neurosurg., 56 (1991) 77-103. The preferred embodiments allow the “physiological midline” to be found by testing, and to be programmed accordingly.

Recording of electrical signals is quite difficult, and very dependent on distance from the active tissue, direction of action potentials in axons, and especially on the area/impedance of the recording site (low impedance picks up potentials from larger distances, but signals are small). By picking the right locations of recording sites, and adding or subtracting neighboring site signals, the best signal can be obtained.

Being able to select and activate electrodes from a large number of possible sites provided by the preferred embodiments is valuable in case any site becomes unusable due to mechanical/electrical problems, scar tissue, etc. A near neighboring site might give almost as useful a result.

Currently the only way to select optimal electrode sites (beyond polarity choices) is by surgical positioning of the lead, which might be unreliable over time because positioning was done with the patient in one body position, and can change by migration of the lead. There have been proposals for leads that can have configuration changes, but these proposals do not offer the advantage of the preferred embodiments.

Advantageous uses for leads L1-L5 described in this specification include:

a. Over or in motor cortex or cerebellar cortex, where there are somatotopic maps of the body, and where fine control of the loci of excitation can help affect the movements or control of various body parts;

b. Over or in the sensory cortex, which also has a somatotopic map, so that paresthesia and/or motor effects can be adjusted to specific body parts;

c. In the thalamus, where there is a three-dimensional body map, and where there are lamina of cells that might best be activated (or partly activated) using many contacts and programming.

d. In deep tissue, where stimulation is advantageously achieved by cylindrical leads;

e. Transversely and over the cauda equina (nerves in the spinal canal descending from the tip of the cord) to enable great selectivity of stimulation;

f. In the cochlea, where there is insufficient space for many wires, but many channels are needed and where fine-tuning which sites along the cochlea get stimulated might lead to much better hearing;

g. Over branches of motor nerves or large nerves, to activate distinct fascicles; and

h. In the retina, where if a patient has no light going to the back of the eye, the preferred embodiment could stimulate in neural patterns as if light were going there in focus and being perceived.

The controller chips disclosed in this specification preferably are rigid, made of silicon, with a hermetically sealed cover. However, they may be quite small. Of course, the controller chips may be made of any other known, or later developed, material suitable for integrated circuits. All other parts of leads L1-L5 may be flexible.

Another advantage of leads L1-L5 is that a number of recording sites could be programmed in parallel to constitute a stimulation site which generally requires a low impedance and larger surface area. Several stimulation sites may be programmed together to reduce the impedance.

As disclosed in FIG. 14, another embodiment of the present invention is a percutaneous lead 100 having a plurality of electrodes 110-1 through 110-N (collectively referred to as 110) along the distal end 101 of lead 100. Each electrode 110 has a corresponding controller 115-1 through 115-N (collectively referred to as 115) adjacent to and associated with each electrode 110. Each controller 115 is preferably coupled to signal generator 102 via power conductors 120 and 125, one conductor providing stimulation pulses and the other providing common ground. Controllers 115 may be coupled to a main controller 103 via data conductor 130. Main controller 103 is preferably a microprocessor, which may be part of signal generator 102. Main controller 103 may identify an electrode, or electrodes, 110 to provide electrical stimulation provided by signal generator 102. Each corresponding controller 115 may be uniquely identifiable such that a control signal from main controller 103 may identify the corresponding controller, or controllers, 115 to allow its associated electrode, or electrodes, 110 to deliver electrical stimulation. Control signal information may be provided from main controller 103 to corresponding controllers 115 via data conductor 130.

Percutaneous lead 100 of the present invention may be constructed using a number of known techniques. In one embodiment, distal end 101 of lead 100 may be composed of modular components 135-1 and 135-2 (collectively 135), 140 and 145 that can be assembled using one or more electrode components 135, one or more lead components 140, and a tip component 145 as shown in FIG. 15. Conductors 120, 125, and 130 of adjoining components 135 and 140 may be coupled by welding, by male/female connections, or any other technique known in the art. Electrode component 140 is preferably constructed by placing corresponding controller 115, preferably an IC chip, on the interior of electrode component 140 with an epoxy-like glue (similar to electrical circuits CT1 and CT2 of FIGS. 7 and 8). Controller 115 may be electrical switches or gates which activate specified electrodes in the assembly in accordance with data received on conductor 130 from main controller 103. If there is only one electrode at each longitudinal position of the lead, it could be a ring electrode. If there is more than one electrode at each longitudinal position, the electrodes at each longitudinal position could occupy sectors of the cross-section of lead 100. Then, by use of signal generator 102, only those electrodes nearest the excitable tissue could be used for stimulating.

Using modular components, such as, for instance, those shown in FIG. 15, a physician, or other suitable health care professional, may assemble a customized lead capable of delivering stimulation at particular locations within a patient's body. Such customized assembly provides increased flexibility for placing the electrodes of a lead at selected locations within a patient's body as compared to leads assembled in various standardized configurations.

FIG. 16 discloses a simplified circuit diagram of a corresponding controller 115 in accordance with the present invention. Power conductors 120 and 125 and data conductor 130, described in connection with FIG. 14, are shown in FIG. 16. Controller 115 may include a decoding module 150 for selectively opening or closing three-way switch 155 upon receiving from main controller 103 a key that uniquely identifies electrode 135 and that may specify a stimulation polarity for the identified electrode. Decoding module 150 may include a hard-coded key uniquely identifying each electrode 135. Three-way switch 155 allows electrode 135 to have individually selected polarities depending by placing switch 155 in an appropriate position based upon an optionally specified polarity in the key received from main controller 103. In this manner, main controller 103 may identify electrodes, and optionally respective polarities, in appropriate sequences to be energized, thereby stimulating electrically excitable tissue while using a percutaneously implantable lead including relatively few wires coupling controllers 115 and electrodes 135 to signal generator 102.

Those skilled in the art recognize that the preferred embodiments may be altered and modified without departing from the true spirit and scope of the invention as defined in the appended claims. For example, the electrodes may be planar and of any shape (e.g., round, oval, and rectangular). The electrodes also may have three dimensional outer surface (e.g., cylindrical, spherical, semispherical or conical). Multiple leads having multiple electrodes may be used simultaneously in accordance with this invention.